A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

A Phase 2 study of Ischemic Stroke, run by Acorda Therapeutics at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Ischemic Stroke
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 20 sitesUnited States
Study dates: May 2012to Mar 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)
≥ 6 months post-stroke
Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
Stable concomitant medication therapy regimen within 4 weeks of screening visit

Who cannot join

History of seizures, except simple febrile seizures
Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
Botulinum toxin use within 2 months prior to the Screening Visit
Orthopedic surgical procedures in any of the extremities within the past 6 months
Diagnosis of multiple sclerosis

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Acorda Site #002
Atlantis, Florida, 33462
Acorda Site #010
Bellevue, Washington, 98004
Acorda Site #011
Birmingham, Alabama, 35294
Acorda Site #009
Boston, Massachusetts, 02118
Acorda Site #019
Buffalo, New York, 14220
Acorda Site #013
Charlotte, North Carolina, 28207
Acorda Site #003
Decatur, Georgia, 30033
Acorda Site #006
Fairfield, Connecticut, 06824
Acorda Site #015
Fort Lauderdale, Florida, 33308
Acorda Site #020
Great Falls, Montana, 59405
Acorda Site #018
La Jolla, California, 92103
Acorda Site #021
Lexington, Kentucky, 40513
Acorda Site #022
New Brunswick, New Jersey, 08901
Acorda Site #016
Newport Beach, California, 92663
Acorda Site #008
Norfolk, Virginia, 23507
Acorda Site #001
Philadelphia, Pennsylvania, 19104
Acorda Site #023
Reno, Nevada, 89502
Acorda Site #017
Saginaw, Michigan, 48604
Acorda Site #007
West Haverstraw, New York, 10993
Acorda Site #004
White Plains, New York, 10605

Other trials in United States

About this study

Conditions: Ischemic Stroke
Being tested: placebo/dalfampridine-ER, dalfampridine-ER/placebo
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placebo/dalfampridine-ERDrug
Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
dalfampridine-ER/placeboDrug
Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Study groups in NCT01605825
Study group	Role	What they receive
placebo/dalfampridine-ER	Placebo comparator	Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 Receives: Drug: placebo/dalfampridine-ER
dalfampridine-ER/placebo	Placebo comparator	Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 Receives: Drug: dalfampridine-ER/placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment.
The severity categories of mild, moderate or severe, are defined below:
- Mild is defined as causing no limitation of usual activities
- Moderate is defined as causing some limitation of usual activities
- Severe is defined as causing inability to carry out usual activities
Measured: up to 36 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Mar 2013

First posted25 May 2012 (estimated)
Study startMay 2012
Primary completionFeb 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01605825
Sponsor's protocol ID: DALF-PS-1003
Status last verified: Dec 2015
First submitted: 21 May 2012
Last updated: 22 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Iaci JF, Parry TJ, Huang Z, Finklestein SP, Ren J, Barrile DK, Davenport MD, Wu R, Blight AR, Caggiano AO. Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion. Stroke. 2013 Jul;44(7):1942-50. doi: 10.1161/STROKEAHA.111.000147. Epub 2013 May 7.
PubMed 23652269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
ClinicalTrials.gov ID: NCT01605825
Acronym / sponsor ID: DALF-PS-1003
Conditions: Ischemic Stroke
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Acorda TherapeuticsIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Feb 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 25 May 2012 (estimated)
Results: Posted 10 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
placebo/dalfampridine-ER	Placebo comparator	Drug: placebo/dalfampridine-ERSubjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
dalfampridine-ER/placebo	Placebo comparator	Drug: dalfampridine-ER/placeboSubjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)
≥ 6 months post-stroke
Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
Stable concomitant medication therapy regimen within 4 weeks of screening visit

Key exclusion criteria (5 listed)

History of seizures, except simple febrile seizures
Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
Botulinum toxin use within 2 months prior to the Screening Visit
Orthopedic surgical procedures in any of the extremities within the past 6 months
Diagnosis of multiple sclerosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebo/dalfampridine-ERSequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart	Drug	placebo/dalfampridine-ER
dalfampridine-ER/placeboSequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart	Drug	dalfampridine-ER/placebo

Primary outcome

Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 36 days
A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of usual activities * Moderate is defined as causing some limitation of usual activities * Severe is defined as causing inability to carry out usual activities

Results and safety

Results posted to the registry on 10 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Dalfampridine-ER	55	45
Dalfampridine-ER/Placebo	28	25

Primary outcome: Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)

Time frame: up to 36 days. Number. Unit: participants

Measure	Placebo n = 81	Dalfampridine-ER n = 77
Subjects with any TEAEs	30	42
TEAEs Possibly Related to study drug	16	24
TEAEs Maximum Severity - Mild	16	29
TEAEs Maximum Severity - Moderate	13	10
TEAEs Maximum Severity - Severe	1	3
TEAEs leading to withdrawal of study drug	1	5
TEAEs Serious	2	2
Subjects who died	0	0

Population analysed: Safety population. Number of participants analyzed is number of patients with TEAE's as described in outcome measure description. Excludes pre-treatment and post-treatment adverse events.

Adverse events

Time frame: up to 36 days. Other adverse events reported at 1.3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 81 (2.5%)	30 of 81 (37%)	Not reported
Dalfampridine-ER	2 of 77 (2.6%)	42 of 77 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23652269Iaci JF, Parry TJ, Huang Z, Finklestein SP, Ren J, Barrile DK, Davenport MD, Wu R, Blight AR, Caggiano AO. Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion. Stroke. 2013 Jul;44(7):1942-50. doi: 10.1161/STROKEAHA.111.000147. Epub 2013 May 7.

Related trials for Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mathews Adera, MD study director

Acorda Therapeutics

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Ischemic Stroke, run by Acorda Therapeutics at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) (time frame: up to 36 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01605825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.